Kornimate/medical-research-clean huggingface dataset:
evaluation of the performances of the sleep disordered breathing monitoring function in pacemaker

Conditions: Bradycardia

Summary: the ibsy04 clinical investigation is an european, prospective, multi-centre, non-randomized, longitudinal study.

the purpose of this study is to assess the performance of sleep disordered breathing monitoring function (sdb) in pacemakers by comparing device diagnostic data to the results of in-lab polysomnography (psg) recording during the same night

Eligibility criteria:
inclusion criteria: any patient enrolled in the study must fulfil all of the following criteria: * patients eligible for implantation of a single or dual-chamber pacemaker according to current available guidelines * patients who are scheduled for implant of a reply 200 sr; or reply 200 dr pacemaker * patients who provide signed and dated informed consent exclusion criteria: * inability to understand the purpose of the study or refusal to co-operate * unavailability for scheduled follow-ups at the implanting centre * already included in another clinical study that could affect the results of this study * inability or refusal to provide informed consent * patient is minor (less than 18-years old) * patient is pregnant (women of childbearing potential should have a negative pregnancy test prior to enrolment) * patient is forfeiture of freedom or under guardianship
effect of cp-690,550 on the pharmacokinetics of metformin in healthy volunteers

Conditions: Rheumatoid Arthritis

Summary: this study will evaluate the potential effect of cp 690,550 on the pharmacokinetics of metformin, a probe drug for organic cationic transport.


Eligibility criteria:
inclusion criteria: * adult healthy male and/or female (of non child bearing potential) subjects. exclusion criteria: * subjects with clinically significant systemic and laboratory abnormalities. * subjects with clinically significant infections within the past 3 months. * women of child-bearing potential.

Keywords: drug-drug interaction healthy volunteers cp-690 550 metformin
effect of glycerol trierucate on clinical course of adrenoleukodystrophy

Conditions: Adrenoleukodystrophy

Summary: objectives: i. evaluate the clinical efficacy of combination glyceryl trierucate and glyceryl trioleate (lorenzo's oil) therapy in boys with x-linked adrenoleukodystrophy. ii. compare the frequency and severity of neurological disability of study patients with untreated historical controls.

protocol outline: this is an open label study. patients must follow dietary instructions as provided by the investigator. patients receive 2-4 tablespoons of a mixture of glyceryl trierucate and glyceryl trioleate oil once daily. patients complete a neuropsychological scoring scale questionnaire to measure neurological disability. patients undergo physical examinations including magnetic resonance imaging and magnetic resonance spectroscopy of the head. patients are followed monthly for 6 months, then every 3 months until they reach the age of 13 years or death.

Eligibility criteria:
inclusion criteria. 1. boys between the age of 18 months and 8 years of age 2. biochemically proven asymptomatic x-linked adrenoleukodystrophy determined by elevation of very long chain fatty acids or dna analysis. 3. platelet count in normal range exclusion criteria. 1. abnormal mri consistent with childhood cerebral disease 2. boys who have undergone bone marrow transplantation 3. other medical condition which in the opinion of the investigator prevents evaluation or treatment

Keywords: adrenoleukodystrophy inborn errors of metabolism rare disease sphingolipidoses
left atrial appendage ligation using the atriclip device

Conditions: Left Atrial Appendage Ligation

Summary: the purpose of the study is to collect data regarding ligation of the left atrial appendage at least 12 months after surgery for patients that had exclusion of the left atrial appendage as a primary minimally invasive procedure or in conjunction with other open cardiac or minimally invasive cardiac procedures.

the purpose of this study is to collect data regarding ligation of the left atrial appendage at least 12 months after surgery for patients that had exclusion of the left atrial appendage as a primary minimally invasive procedure or in conjunction with other open cardiac or minimally invasive cardiac procedures. the patient will undergo a transesophageal echocardiogram (tee) to collect the following data: left ventricular ejection fraction; left atrial diameter size; confirmation of left atrial appendage exclusion defined by the absence of left atrial to laa (left atrial appendage) communication measured in millimeters and absence of laa pocket measured in millimeters; presence of thrombus in left atrium.

Eligibility criteria:
inclusion criteria: * all adult patient who had a heart procedure where an atriclip device was deployed as the primary or secondary procedure between 3/2013-12/20/2016 * patient is willing to undergo a trans esophageal echocardiogram, or if unable a ct angiogram * if female, must be of non-childbearing potential or have a negative pregnancy test within 7 days prior to the procedure * patient is willing to sign an irb approved informed consent exclusion criteria: * patient did not have an atriclip device as part of the surgical procedure between 3/2013 and 12/2016. * patient is unwilling or unable to undergo trans esophageal echocardiogram with general anesthesia or a ct angiogram

Keywords: left atrial appendage ligation atriclip atrial fibrillation
the effectiveness of cross-training on an immobilised forearm

Conditions: Forearm Fracture

Summary: the cross-training phenomenon is the increase in muscle strength in the contralateral limb when one limb is exercised. limited studies have shown that it prevents immobilisation-induced muscle weakness in healthy volunteers. the aim of this study was to evaluate the effect of strengthening the contralateral extremity on muscle strength and range of motion in the immobilised extremity in patients who had undergone immobilisation for forearm fractures.


Eligibility criteria:
inclusion criteria: * traumatic unilateral forearm fracture (treated surgically or conservatively and immobilised in a cast) exclusion criteria: * previous upper limb surgery/joint disease - deformity affecting hand-wrist function * any neurological condition affecting the upper extremity (stroke, parkinson's disease; multiple sclerosis, reflex sympathetic dystrophy, peripheral nerve injury)

Keywords: fracture immobilisation cross-education muscle strength
chinese ckd-mbd prevalence survey (criss-mbd)

Conditions: Chronic Kidney Diseases; Chronic Kidney Disease-Mineral and Bone Disorder

Summary: this is a multi-center cross sectional epidemiological study. the purpose of this study is to investigate the prevalence of chronic kidney disease-mineral and bone disorder (ckd-mbd) in chinese population.

the prevalence of chronic kidney disease (ckd) in chinese population is over 10% and increasing rapidly. chronic kidney disease-mineral and bone disorder (ckd-mbd) is a constellation of conditions secondary to ckd, including 1) metabolic disorders of calcium, phosphorus and parathyroid hormone (pth), 2) bone diseases and 3) calcifications in blood vessels and soft tissues. ckd-mbd could increase the risks of cardiovascular diseases and bone fracture and overall mortality. however, the data of prevalence of ckd-mbd in chinese population with different ckd stages is lacking. this is a multi-center cross sectional epidemiological study. the purpose of this study is to investigate the prevalence of chronic kidney disease-mineral and bone disorder (ckd-mbd) in chinese population.this is a multi-center cross sectional epidemiological study. the purpose of this study is to investigate the prevalence of chronic kidney disease-mineral and bone disorder (ckd-mbd) in chinese population. a questionnaire was designed to collect the information of demographic data, medical history, laboratory test results and medications from the patients. multistage stratified cluster sampling method will be used. based on the sample size estimation, a total of 14-28 tertiary hospitals and 42-56 level ii hospitals distributed in seven different geographic regions across china will be included. at least 9863 subjects will be enrolled. the primary outcome is the prevalence of ckd-mbd, including the prevalence of hypocalcemia, hyperphosphatemia and secondary hyperparathyroidism.

Eligibility criteria:
inclusion criteria: * kidney damage for ≥ 3 months, and one of the following criteria: 1. glomerular filtration rate (gfr) \<60 ml/min/1.73m2 for 3 months or more, irrespective of cause. 2. proteinuria (\>30 mg of urinary albumin excretion per gram of urinary creatinine, \> 50 mg of urinary protein excretion per gram of urinary creatinine, \>1+ for proteinuria in dipstick, \> 0.3g of 24 hour urine protein) 3. structural renal abnormalities * hospitalized patients not on dialysis or dialysis patients followed regularly in hemodialysis centers or peritoneal dialysis centers exclusion criteria: * no available test results within 3 months prior to this study * no available information of medication or past medical history

Keywords: chronic kidney diseases chronic kidney disease-mineral and bone disorder hypocalcemia hyperphosphatemia secondary hyperparathyroidism
effect of dexamethasone implant on optic disc

Conditions: Glaucoma and Ocular Hypertension; Diabetic Macular Edema; Intravenous Drug Usage; Optic Disk Disorders

Summary: this study evaluates the effect of dexamethasone implant which is an intraocular corticosteroid on the optic nerve fibers. retinal nerve fiber thicknesses and optic nerve head pitting rates were measured before and 6 months after the injection.

diabetic macular edema is the most frequent ocular complication of diabetes resulting in irreversible loss of vision if untreated. dexamethasone implant implant is used to treat macular edema due to diabetes. it stay in the vitreous for 6 months after intravitreal administration. dexamethasone implant can lead to retinal nerve fiber layer and optic nerve damage by both increasing intraocular pressure and its direct effect on neural tissue during the effective 6-month period.

Eligibility criteria:
inclusion criteria patients who underwent first time intravitreal injection exclusion criteria previously received any surgery proliferative diabetic retinopathy glaucoma or glaucoma suspicion optic disc fatigue optic disc edema uveitis and media opacity blurred of image clarity

Keywords: diabetic maculopathy dexamethasone implant optic disc vascular endothelial growth factor
immune induction strategies to improve response to immune checkpoint blockade in triple negative breast cancer (tnbc) patients

Conditions: Metastatic Breast Cancer

Summary: this is a single center non-blinded randomized multi-cohort non-comparative phase ii trial with a simon's two-stage design.

in the first stage, 13 evaluable patients will be accrued per cohort. evaluable is defined as: at least one administration of nivolumab and availability of paired biopsies for immunohistochemistry (for induction treatment cohorts pre-induction and pre-nivolumab biopsies). if there are 1 or no responses observed in these 13 patients, the cohort will be stopped. otherwise, 21 additional patients will be accrued for a total of 34.

Eligibility criteria:
inclusion criteria: * metastatic or incurable locally advanced triple negative breast cancer (er \< 10%, her2 ihc 0,1+ or 2+ with no amplification) * metastatic lesion accessible for histological biopsy * 18 years or older * maximum of three lines of chemotherapy for metastatic disease and with evidence of progression of disease. treatment with low-dose doxorubicin in the palliative setting is not allowed. * who performance status of 0 or 1 * measurable or evaluable disease according to recist 1.1 * disease free interval (defined as time between first diagnosis or locoregional recurrence and first metastasis) longer than 1 year * subjects with brain metastases are eligible if these are not symptomatic and free of progression of at least 4 weeks * a maximum dosage of 360 mg/m2 of anthracyclines and no previous anthracycline-related cardiac toxicity. in case of radiation in the cardiac area, hypertension, diabetes mellitus or hypercholesterolemia, the left ventricular ejection fraction must be 50% or higher. * adequate bone marrow, kidney and liver function exclusion criteria: * uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris * known history of leptomeningeal disease localization * history of having received other anticancer therapies within 2 weeks of start of the study drug * history of immunodeficiency, autoimmune disease, conditions requiring immunosuppression (\>10 mgl daily prednisone equivalents) or chronic infections. * prior treatment with immune checkpoint inhibitors. * active other cancer * history of uncontrolled serious medical or psychiatric illness * current pregnancy or breastfeeding

Keywords: triple negative metastatic disease
toripalimab in combination with chemotherapy and antiangiogenic agents in patients with non-small cell lung cancer after failure of immunotherapy (pd-1/l1 inhibitors)

Conditions: Non Small Cell Lung Cancer Recurrent

Summary: this is a phase ii, single arm, open-label, single-center study to evaluate the efficacy and safety of toripalimab combined with chemotherapy and antiangiogenic agents in patients with non-small cell lung cancer after failure of immunotherapy (pd-1/l1 inhibitors)


Eligibility criteria:
inclusion criteria: * patients voluntarily participate in this study, signed and dated informed consent with good compliance and follow-up; * diagnosed as locally advanced and / or metastatic non-small cell lung adenocarcinoma (nsclc) by cytology or histology; * first-line pd-1/pd-l1 inhibitors treatment failure; * provide detectable specimens (tissue or blood) for genotyping before enrollment, and the patients should be with negative egfr and alk gene test results; * had at least one measurable lesion according to recist 1.1 criteria * anticipated overall survival more than 3 months; * ecog (eastern cooperative oncology group) scale 0-2; * normal organ function and bone marrow function; * resistant to first-line immune checkpoint inhibitor therapy and discontinued for more than 4 weeks; * women of childbearing age must have taken reliable contraceptive measures and performed a pregnancy test (serum or urine) within 7 days prior to enrollment, and the results were negative, and were willing to use appropriate methods during the trial and 4 weeks after the last administration of the test drug. exclusion criteria: * patients with small cell lung cancer (including small cell carcinoma and non-small cell carcinoma mixed lung cancer) ; * patients who have previously permanently discontinued immunotherapy due to immune-related serious adverse reactions; * patients who previously treated with antiangiogenic agents; * a history of other malignancies within 5 years prior to inclusion, except for cervical carcinoma in situ, basal or squamous cell skin cancer, localized prostate cancer treated with radical surgery, and ductal carcinoma in situ treated with radical surgery; * active, known or suspected autoimmune disease; * active or chronic hepatitis c or/and hepatitis b infection; * history of interstitial lung disease.
the biology of chronic preconditioning: genomic and physiologic mechanisms of response

Conditions: Ischemic Preconditioning

Summary: the purpose of this study is to assess the effects of repeated ripc and exercise, on exercise performance, skeletal muscle responses and circulating cellular and humoral biology in humans

remote ischemic preconditioning (ripc) results in a powerful and widespread protective effect against subsequent prolonged ischemia-reperfusion (ir) injury of distant organs and systemic inflammatory responses, both of which are key elements in the evolution of local and multiorgan effects of many clinical ir syndromes. the signal transduction within the target organ to generate ischemia tolerance, and the effects of ripc on systemic anti-inflammatory pathways, however, remain to be elucidated fully. particularly, data regarding the mechanisms of 'second window' protection (a resurgence of protection 24-72 hrs after the initial ripc stimulus) is scant; even less is known of the effects of repeated ripc, and a potential 'third window' of protection. our preliminary data and several recent publications have shown that the biology of ripc and exercise show considerable overlap. this research has raised the possibility of a reciprocal effect between ripc and exercise, with chronic exercise being a model of the potential effects of 'chronic preconditioning'. this is relevant, as repeated ripc might be a strategy to improve exercise function in those with limited exercise tolerance e.g. heart failure.

Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years, 2. informed consent exclusion criteria: 1. contraindication to exercise, 2. vigorous aerobic/anaerobic exercise in duration of ≥15 minutes during the 21 days prior to commencement of the study, or either of the ripc or exercise protocol arms, 3. overt viral or bacterial infection in the 10 days prior to commencement of the study, or during either of the ripc or exercise protocol arms, 4. alcohol and/or caffeine consumption in the 10 days prior to, or at any time during the study period 5. pregnancy

Keywords: pediatrics remote ischemic preconditioning
evaluation of macro and microcirculatory arterial condition of the upper limb in insufficiently renal patients

Conditions: Arteriopathy Upper Limb; Renal Insufficiency; Digital Pressure

Summary: evaluation of macro and microcirculatory arterial condition of the upper limb in insufficiently renal patients hand ischemia affects 1.6 to 8% of patients with arteriovenous fistula (fav) of hemodialysis in the upper limb. the diagnostic and therapeutic stakes are major as it concerns the functional prognosis of the hand and, to a lesser extent, vascular access for hemodialysis. in some cases, the diagnosis of ischemic hemo-hijacking is evident, in other cases, the ischemic condition appears to be rather the result of uncompensated arteriatory of the upper limb or limbs. echo-doppler exploration is usual for assessing vascular access but without validated formal criteria for arterial disease in the upper limbs, with fistula flow calculation and analysis of fav hemodynamics. compression manoeuvres on or under the fav can also be performed. the pressures of the digital arteries are also indicated with non-consensual values found in the literature for the diagnosis of digital ischemia but with varying tools in terms of collection of measurements. the main objective of this study is to collate the characteristics of arterial condition of the upper limbs of medium or severe renal patients, medium- or short-term candidates for kidney dialysis. the data collected will match the data of the arterial echodoppler as well as measures of pressures doppler laser and plethysmography. candidates for dialysis tend to be older and polyvascular. a better assessment of the vascular condition of their upper limbs, including the diagnosis of advanced arterial disease, could eventually guide the choice of type of dialysis (compared to an indication of fav).

prospective, monocentric study the main objective of the research description of the arterial condition of the upper limbs of kidney failure patients candidates for dialysis primary search judgment criterion: description of the ultrasound characteristics of the arterial echo-doppler of the upper limbs.

Eligibility criteria:
inclusion criteria: * chronic renal failure patient with nephrologist's decision to pre-dialysis or chronic renal insufficient patient with arteriovenous fistula of the upper limb and sign of digital ischemia (cold hand, digital ulcer, digital necrosis) agreement on the study's non-opposition form age above or equal 18 years patient affiliated with a social security plan exclusion criteria: * subject under guardianship or subject deprived of liberty failure to obtain patient's consent
novel method to assess hepatic regeneration and predict hepatic related morbidity after partial hepatectomy

Conditions: Liver Cancer Adult; Liver Regeneration

Summary: the investigators will pursue two specific aims: (1) to monitor the extent of heme oxygenase induction (by measuring endogenous co production) in relationship to the extent of hepatic resection (2) to assess the production of co in patients following liver resection and correlate these findings to the rate of liver regeneration and liver function.


Eligibility criteria:
inclusion criteria: * patient plans to have partial liver resection for primary liver pathology or metastatic disease * patient is able to comprehend and willing to sign the written consent form exclusion criteria: * patients \< 18 years * patients identified as members of a vulnerable population, except women of child bearing potential with negative pregnancy test

Keywords: hepatectomy
bacterial lysates on respiratory tract microecology and evaluation of the efficacy of prevention and treatment of vap

Conditions: Ventilators, Mechanical

Summary: the purpose of this study is to assess the effect of bacterial lysates on respiratory tract microecology in patients with mechanical ventilation and the efficacy of prevention and treatment of ventilator associated pneumonia.

after being informed about the study and potential risks, all patients giving written informed consent will undergo a one-week screening period to determine eligibility for study entry. at week 0, patients who meet the eligibility requirements will be randomized in a double-blind manner in a 1:1 ratio to bacterial lysates( 14mg, once a day) or placebo(once a day).

Eligibility criteria:
inclusion criteria: * patients admitted to icu for mechanical ventilation * the expected mechanical ventilation time is more than 72h * sign the informed consent form when conscious and voluntary, and complete the questionnaire survey and follow-up as required; if it is unable to sign the informed consent form and complete the questionnaire survey and follow-up, the legal representative or guardian can act on behalf of it. exclusion criteria: * ventilator associated pneumonia is known and confirmed * pregnant or lactating female * allergic to the active ingredients of bacterial lysates or any excipients listed in the ingredients * patients with autoimmune diseases * patients with acute intestinal infection * patients participating in other clinical studies at the same time * patients considered unsuitable by other researchers to participate in this study

Keywords: ventilators; bacterial lysates; microecology; pneumonia